FDA Says Pradaxa Stomach Bleed Risk Higher Than Warfarin

The FDA has released an updated drug safety communication indicating that the anticoagulant dabigatran (Pradaxa), while offering certain benefits, carries an increased risk of major gastrointestinal bleeding when compared to warfarin (Coumadin, Jantoven, and generics), its much older market competitor.

The findings are based on a recently completed study of 134,000 Medicare patients aged 65 or older. The FDA reported that using Pradaxa, manufactured by Boehringer Ingelheim, increased the risk of stomach bleeds by 28%, with 34.2 bleeding incidents for every 1,000 person-years of use. There were only 26.5 gastrointestinal bleeding incidents reported by warfarin users over the same span.

FDA says Pradaxa benefits still outweigh risks

While the potential gastrointestinal side effects of Pradaxa are significant, the FDA also noted that Pradaxa was associated with a lower risk of clot-related strokes, brain bleeds, and death. Pradaxa carried only 80% of the risk of stroke when compared to warfarin, and a third of the risk of brain bleeding. The risk of heart attacks was about the same for both drugs, and the mortality rate for Pradaxa patients was slightly lower.

The FDA, while acknowledging the heightened incidence of stomach bleeds, said that no additional labeling changes need to be made in light of the decreased stroke, heart attack, and mortality rates. The current Pradaxa FDA warning is that patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. It also indicates that stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death.

The agency has recently expanded the approved uses of Pradaxa to include prevention of deep vein thrombosis and pulmonary embolism.

Pradaxa maker says it’s “no worse” than warfarin; MDs not convinced

A study sponsored by the manufacturer Boehringer Ingelheim and published online in the medical journal Circulation, favorably compared outcomes for patients who suffered major bleeding events while taking Pradaxa, to patients who suffered bleeding events while taking warfarin. The study claimed that patients who suffered Pradaxa bleeds had shorter hospital stays and tended to be more likely to survive than warfarin patients.

However, the new FDA information is based on a much larger and older patient population than the Boehringer study and in the FDA’s view employed a more sophisticated analytical method to capture and analyze the events of concern.

Unlike Pradaxa, bleeding events among users of warfarin can typically be stopped through use of vitamin K and plasma, known as a reversal agent. No such antidote exists for Pradaxa, often leaving doctors unable to stop severe bleeds that may occur while using the medication.

Pradaxa FDA warning comes as result of record number of adverse events

First approved by the FDA in October 2010 for stroke prevention for atrial fibrillation patients, Pradaxa was promoted as a replacement for warfarin since patients required less monitoring during treatment. However, Pradaxa quickly began to rack up a record number of adverse event reports after patients experienced uncontrolled bleeding events. Since its introduction, there have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa, often involving reports of hemorrhage and uncontrollable bleeding.

Currently, there are more than 2,300 Pradaxa lawsuits pending under multidistrict litigation currently centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois. Four bellwether trials have been scheduled to begin September 2014 to gauge how juries will react to testimony and evidence presented which may help facilitate future settlement negotiations. Legal experts believe the cases against Pradaxa may grow to as many as 4,000 including lawsuits filed in state and federal Courts.

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